CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment
of life-threatening conditions in intensive care and cardiac
surgery using blood purification via its proprietary polymer
adsorption technology, announced the upcoming original
presentations at the 37th European Association of Cardio-Thoracic
Surgery (EACTS) Annual Meeting in Vienna, Austria, from October
4-7, 2023, including the second analysis from the international
Safe and
Timely
Antithrombotic
Removal (STAR)
Registry.
Second Analysis of the International
STAR Registry
The International STAR Registry captures high
fidelity data on real-world clinical use and associated clinical
outcomes using CytoSorb® for antithrombotic drug removal (ATR) in
the acute hospital setting. The registry collects cases using
CytoSorb to purify the blood of the major modern antithrombotic
agents* such as Brilinta®/Brilique®, Plavix®, Effient®, Pradaxa®,
Savaysa®/Lixiana®, Xarelto®, and Eliquis® in a variety of clinical
scenarios, but particularly in cardiothoracic surgery, where the
blood thinners can potentially cause serious and even fatal
bleeding. The STAR Registry, not to be confused with the completed
U.S. and Canada STAR-T pivotal trial, is enrolling ahead of
internal projections with plans for ongoing presentations at large,
international conferences.
The first registry analysis entitled, “Insights
from the International Safe and Timely Antithrombotic Removal
(STAR) Registry” was presented at the EuroPCR conference in May
2023, the largest interventional cardiology conference in the E.U.,
attracting 11,500+ participants this year. This analysis included
67 patients from 7 centers in the U.K. and Germany who underwent
coronary artery bypass graft (CABG) surgery within 2 days of
Brilinta® (ticagrelor) administration with a high risk of
perioperative bleeding. The analysis reported no device related
adverse events and low rates of BARC-4 bleeding (6%), reoperation
for bleeding (4%), and 24-hour chest tube drainage (537 ± 231 mL).
BARC-4 bleeding is defined as CABG-related bleeding that includes
at least one of the following: perioperative intracranial bleeding,
reoperation after closure of the chest for the purpose of
controlling bleeding, transfusion of 5 units or more of whole blood
or packed red blood cells within a 48-hour period, or chest tube
output of 2 liters or more within a 24-hour
period.
These results compared favorably to the results,
referred to in the presentation, from an often cited analysis of
the SWEDEHEART registry, the national Swedish registry of all
patients hospitalized for acute coronary syndrome or undergoing
percutaneous coronary intervention or heart surgery, published in
the European Heart Journal. In this study, Hannson and colleagues
reported an average 31.4% incidence of severe BARC-4 bleeding in a
cohort of patients who similarly required CABG surgery within 48
hours of ticagrelor (Brilinta®) administration but did not get
CytoSorb. In addition, patients in this cohort had 12-hour chest
tube drainage (CTD) of 813 ± 478 mL and 641 ± 337 mL following CABG
surgery within 24 and 48 hours, respectively, from last ticagrelor
administration, which was more CTD than seen in patients treated
with CytoSorb in the first STAR Registry analysis, yet in only half
the time. In the entire study, which included patients who had a
chance to wash out the drug for more than 5 days prior to surgery
which accounted for approximately 2/3rds of all patients,
reoperations due to bleeding was 6.1%.
The second analysis of the International STAR
Registry being presented at the 2023 EACTS conference next week,
entitled “Intraoperative hemoadsorption for antithrombotic drug
removal during cardiac surgery: the International Safe and Timely
Antithrombotic Removal (STAR) Registry,” summarizes the use of
CytoSorb in patients on blood thinners undergoing a much broader
range of heart surgeries than reported previously, mixing isolated
CABG patients with more complex and invasive procedures at higher
risk of perioperative bleeding including valve replacement, CABG +
valve replacement, aortic surgery, and heart transplant. It also
includes, for the first time, data on patients being treated with
CytoSorb to reduce seven different antithrombotic medications. The
analysis is divided between two groups: 114 patients on
antiplatelet drugs including Brilinta® (ticagrelor), Plavix®
(clopidogrel), and Effient® (prasugrel); and 51 patients on the
direct oral anticoagulants (DOACs) including Eliquis® (apixaban),
Xarelto® (rivaroxaban), Savaysa®/Lixiana® (edoxaban), and Pradaxa®
(dabigatran). The overall study population was taken from 8 centers
in Germany, the United Kingdom, Austria, and Sweden.
The antiplatelet analysis focuses on the use of
intraoperative CytoSorb on 114 patients on antiplatelet agents
undergoing isolated CABG (78%), or higher risk cardiothoracic
surgeries including valve replacement, aortic surgery, and heart
transplant (22%). The rate of BARC-4 bleeding for isolated CABG
surgery alone was 4.5%, while overall BARC-4 bleeding was 13.2%,
reflecting the higher bleeding risk of the more complex surgeries
and the use of Plavix® (17%) and Effient® (3%), historically
thought to be irreversible platelet inhibitors, in 20% of the
patients. In the future, in addition to generating more data on the
clinical impact of removing Brilinta®/Brilique®, the STAR Registry
is also expected to help answer the question of whether CytoSorb
can mitigate the bleeding risk in patients on Plavix® and Effient®
in ways not related to drug binding to the platelet.
The Direct Oral Anticoagulant (DOAC) analysis
reports on the use of CytoSorb intraoperatively in patients on
Eliquis® (47%), Xarelto (27%), Savaysa®/Lixiana® (24%), and
Pradaxa® (2%) undergoing a more evenly divided set of procedures
including isolated CABG (23.5%), CABG + valve replacement (15.7%),
isolated valve replacement (17.6%), Aortic surgery (15.7%), and
other procedures (27.5%). There was no BARC-4 bleeding in the 12
patients undergoing isolated CABG surgery, with 15.7% BARC-4
bleeding overall, reflecting the higher proportion of higher risk
and more invasive surgeries.
The international STAR Registry authors
concluded that for this analysis, for “patients undergoing cardiac
surgery before the recommended washout period, the use of
intraoperative antithrombotic drug removal is associated with lower
incidence of serious bleeding compared with historical rates,” and
“importantly, no serious device-related adverse events were
observed.”
Dr. Efthymios Deliargyris, Chief Medical Officer
of CytoSorbents, stated, “We believe the STAR Registry provides a
powerful platform to systematically collect high quality,
real-world outcomes data on the ability of CytoSorb to reduce
perioperative bleeding risk in patients on a variety of
antithrombotic drugs undergoing cardiothoracic surgery on an
international scale. Given that DrugSorb-ATR uses an equivalent
polymer technology as CytoSorb, we believe the outcomes seen in the
STAR registry analysis are encouraging and provide greater insights
into the clinical benefits of antithrombotic removal that are also
investigated in our U.S. and Canada STAR-T and STAR-D
programs.”
Other Key Presentations at
EACTS
In addition to the STAR Registry analysis,
another study was selected for presentation entitled,
“Antithrombotic drug removal during off-pump coronary artery bypass
grafting using hemoadsorption” highlighting the successful use of
CytoSorb, in conjunction with a simple hemoperfusion machine, to
prophylactically remove Brilinta® or Xarelto® during off-pump CABG
surgery. According to the study investigators, Mair et al., stated,
“Decoupling of the hemoadsorber from the cardiopulmonary bypass
machine will open new future indications in various medical
specialties (e.g. trauma, neurosurgery) and in emergency patients
on antithrombotic medication.”
CytoSorbents will also host a satellite research
symposium on Friday, October 6, 2023 at 12:15-13:30 CET.
Hemoadsorption with CytoSorb after 10
years – Where do we stand?Chairs: Sandra Lindstedt
(Sweden) and Piotr Suwalski (Poland)
- The Paris experience – Which patients benefit most?Guillaume
Lebreton, France
- The Oslo experience – Removal of antithrombotics to reduce
complications and costsGry Dahle, Norway
- The Essen experience – Hemoadsorption in aortic surgeryHeinz
Jakob, Germany
*These trademarks are owned by their respective
pharmaceutical manufacturers: Eliquis® (Pfizer, BMS), Xarelto®
(Bayer, Janssen), Brilinta®/Brilique® (AstraZeneca), Plavix® (BMS,
Sanofi), Effient® (Daiichi Sankyo, Eli Lilly), Savaysa®/Lixiana®
(Daiichi Sankyo), and Pradaxa® (Boehringer Ingelheim)
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader in the
treatment of life-threatening conditions in the intensive care unit
and in cardiac surgery through blood purification. Its lead
product, CytoSorb®, is approved in the European Union and
distributed in 75 countries worldwide with more than 212,000
devices cumulatively used as of Q2 2023. CytoSorb is an
extracorporeal cytokine adsorber that reduces “cytokine storm” or
“cytokine release syndrome” in common critical illnesses seen in
the ICU and cardiac surgery that can lead to massive inflammation,
organ failure, and a high risk of patient death. Additional CE mark
extensions were granted for bilirubin and myoglobin removal in
clinical conditions such as liver disease and trauma, respectively.
CytoSorb is also E.U. approved to remove the blood thinners,
ticagrelor and rivaroxaban, during cardiothoracic surgery
to reduce the risk of perioperative bleeding. CytoSorb has also
received FDA Emergency Use Authorization in the United
States for use in adult critically ill COVID-19 patients with
impending or confirmed respiratory failure.
Meanwhile, the DrugSorb™-ATR antithrombotic
removal system, based on the same polymer technology as CytoSorb,
targets U.S. FDA and Health Canada marketing approval with the now
completed pivotal STAR-T (Safe and Timely Antithrombotic Removal of
Ticagrelor) randomized, controlled trial. With topline data
expected later this year, the study was designed to evaluate the
potential ability of DrugSorb-ATR to reduce ticagrelor-related
perioperative bleeding when used intraoperatively during cardiac
surgery. DrugSorb-ATR has received two FDA Breakthrough Device
Designations for this application, one to
remove ticagrelor and another to remove the direct
oral anticoagulants (DOAC) apixaban and rivaroxaban, highlighting
these major unmet medical needs.
CytoSorbents’ purification technologies are
based on biocompatible, highly porous polymer beads that can
actively remove toxic substances from blood and other bodily fluids
by pore capture and surface adsorption. Its technologies have
received non-dilutive grant, contract, and other funding of
approximately $48 million from DARPA, the U.S. Department of
Health and Human Services (HHS), the National Institutes of Health
(NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S.
Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM),
Air Force Material Command (USAF/AFMC), and others. The Company has
numerous marketed products and products under development based
upon this unique blood purification technology protected by many
issued U.S. and international patents and registered trademarks,
and multiple patent applications pending, including ECOS-300CY®,
VetResQ®, CytoSorb-XL™, HemoDefend-BGA™, HemoDefend-RBC™,
K+ontrol™, DrugSorb™, ContrastSorb, and others. For more
information, please visit www.cytosorbents.com and
www.cytosorb.com or follow us on Facebook and X
(fka Twitter).
Forward-Looking Statements
This press release includes forward-looking
statements intended to qualify for the safe harbor from liability
established by the Private Securities Litigation Reform Act of
1995. These forward-looking statements include, but are not limited
to, statements about our plans, objectives, future targets and
outlooks for our business, statements about potential exposures
resulting from our cash positions, representations and contentions,
and are not historical facts and typically are identified by use of
terms such as “may,” “should,” “could,” “expect,” “plan,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“continue” and similar words, although some forward-looking
statements are expressed differently. You should be aware that the
forward-looking statements in this press release represent
management’s current judgment and expectations, but our actual
results, events and performance could differ materially from those
in the forward-looking statements. Factors which could cause or
contribute to such differences include, but are not limited to, the
risks discussed in our Annual Report on Form 10-K, filed with the
SEC on March 9, 2023, as updated by the risks reported in our
Quarterly Reports on Form 10-Q, and in the press releases and other
communications to shareholders issued by us from time to time which
attempt to advise interested parties of the risks and factors which
may affect our business. We caution you not to place undue reliance
upon any such forward-looking statements. We undertake no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, other than as required under the Federal securities
laws.
CytoSorbents Contact: Kathleen Bloch(732)
398-5429 kbloch@cytosorbents.com
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